CAR T-CELL Therapy Educational Video Trial

Mass General Brigham

Status: Active, not recruiting

Conditions: Hematologic Malignancy; CAR-T Cell Therapy

Treatments: Behavioral: Educational Video Tool

Study type: Interventional

Funder types: Other

Identifiers

NCT04280133

19-790

Details and patient eligibility

About

The purpose of this study is to test a new educational video to help patients and doctors talk about CAR-T cell therapy, a treatment being used in cancer.

• Educational video tool for patients receiving CAR-T cell therapy.

Full description

This research study is a Feasibility Study, which is the first-time investigators are examining this educational video tool for patients receiving CAR-T cell therapy.

The research study procedures include screening for eligibility, randomization and a series of questionnaires

Participants will be randomized to one of 2 groups:

• Group A: Educational video tool
• Group B: Standard care

Participants will be in the research study for a month after consent

It is expected that about 80 participants will take part in this research study.

Enrollment: 80 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years or age or older
• Established diagnosis of a hematologic malignancy
• Under consideration for CAR T-cell therapy at Massachusetts General Hospital

Exclusion criteria

• Significant uncontrolled psychiatric disorders (psychotic disorder, bipolar disorder, major depression) or other co-morbid disease (dementia, cognitive impairment), which the primary oncologist believes prohibits informed consent or participation in the study
• Undergoing CAR T-cell therapy for solid tumor malignancy
• Inability to comprehend English, as the video is currently only available in English at this time

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Educational Video Tool

Experimental group

Description:

Patients randomized to the intervention arm will watch a 3-minute video educational tool about CAR-T cell therapy prior to admission for CAR-T cell therapy.

Treatment:

Behavioral: Educational Video Tool

Standard Care

No Intervention group

Description:

Patients randomized to the control arm will receive usual care per the treating team. Any questions regarding CAR-T cell therapy will be directed to the patient's medical team